NCT01503333

Brief Summary

The purpose of this school-based trial is to test the efficacy of an intervention to increase moderate to vigorous physical activity (MVPA) among middle school girls. The 17-week "Girls on the Move" (GOTM) intervention has 3 components. Two individual-level components occurring during school hours include: (1) two face-to-face motivational, individually tailored counseling sessions with a school nurse, and (2) an interactive Internet-based session during which each girl receives motivational, individually tailored feedback messages (at 9 weeks). A group-level component, 90-minute Physical Activity (PA) Club provides an important venue after school that includes activities to assist girls in establishing a behavioral pattern of MVPA. The control condition will complete data collection activities and receive their usual school offerings. The investigators hypothesize that immediately post-intervention, minutes of MVPA will be greater by 16 min./wk. in the intervention than control group; At 9 months post-intervention follow-up, minutes of MVPA will be greater in the intervention than control group; and immediately post-intervention, cardiovascular (CV) fitness will be higher and body mass index (BMI) and percent body fat will be lower in the intervention than control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,543

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

November 21, 2018

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

4.7 years

First QC Date

December 23, 2011

Results QC Date

May 25, 2018

Last Update Submit

November 20, 2018

Conditions

Keywords

exerciseadolescentinterventionfemalecounseling

Outcome Measures

Primary Outcomes (1)

  • Minutes of Moderate to Vigorous Physical Activity (MVPA) Post-intervention

    Minutes of MVPA were measured via ActiGraph GT3X+ accelerometers worn on an elastic belt at the right hip for 7 consecutive days, including 5 weekdays and 2 weekend days at post-intervention. Monitors were set to start collecting and storing data in raw format beginning 5:00 A.M. on the day after they were distributed to girls each school. Data were re-integrated to 15-second epochs and processed using established intensity cut-points. One week after distribution, data collectors returned to each school to collect the accelerometers. The majority (1386 \[post-intervention\] of 1519 girls \[baseline\], 91.24%) provided at least 8 hours of data on 3 weekdays and 1 weekend day. An imputation approach based on all available data in hour blocks on all 7 days was implemented. Wear time was standardized to 14 hours/weekday (one hour before each school's actual start time; 7 hours during school; 6 hours after school) and 10 hours/weekend day (later awake time from 11 a.m. to 9 p.m.).

    Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention)

Secondary Outcomes (3)

  • Cardiovascular Fitness (Aerobic Performance)

    Cardiovascular fitness after 17-week intervention (post-intervention)

  • Body Mass Index (BMI) Z-score

    Body mass index z-score at post-intervention (after 17-week intervention)

  • Percent Body Fat

    Percent body fat at post-intervention (immediately after 17-week intervention)

Other Outcomes (7)

  • Minutes of Moderate-to-Vigorous Physical Activity 9-month Follow up

    9 months after the end of the 17-week intervention

  • Perceived Benefits of Physical Activity

    baseline to post-intervention

  • Perceived Barriers to Physical Activity

    Baseline to post-intervention

  • +4 more other outcomes

Study Arms (2)

Control

NO INTERVENTION

The control condition will complete data collection activities and receive their usual school offerings.

Physical activity intervention

EXPERIMENTAL

Receiving Physical activity intervention which includes individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.

Behavioral: Physical activity intervention

Interventions

Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.

Physical activity intervention

Eligibility Criteria

Age9 Years - 14 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • th- 6th- and 7th-grade girls (ages 9-14; 8th-graders if needed in middle schools having only 7th- and 8th- grades)
  • Available and willing to participate in PA Club 3 days/wk. for 17wks.
  • Available for follow-up (9 mos. after intervention ends)
  • Agree to random assignment
  • Able to read, understand, and speak English.

You may not qualify if:

  • Involved in or planning to be involved in school or community sports or other organized PAs, such as dance lessons, that involve MVPA and require participation 3 or more days/wk. after school during every season of the school year
  • A health condition precluding safe MVPA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Related Publications (14)

  • Robbins LB, Pfeiffer KA, Vermeesch A, Resnicow K, You Z, An L, Wesolek SM. "Girls on the Move" intervention protocol for increasing physical activity among low-active underserved urban girls: a group randomized trial. BMC Public Health. 2013 May 15;13:474. doi: 10.1186/1471-2458-13-474.

    PMID: 23672272BACKGROUND
  • Ling J, Robbins LB, Resnicow K, Bakhoya M. Social support and peer norms scales for physical activity in adolescents. Am J Health Behav. 2014 Nov;38(6):881-9. doi: 10.5993/AJHB.38.6.10.

    PMID: 25207514BACKGROUND
  • Vermeesch AL, Ling J, Voskuil VR, Bakhoya M, Wesolek SM, Bourne KA, Pfeiffer KA, Robbins LB. Biological and Sociocultural Differences in Perceived Barriers to Physical Activity Among Fifth- to Seventh-Grade Urban Girls. Nurs Res. 2015 Sep-Oct;64(5):342-50. doi: 10.1097/NNR.0000000000000113.

    PMID: 26325276BACKGROUND
  • Robbins LB, Ling J, Wesolek SM, Kazanis AS, Bourne KA, Resnicow K. Reliability and Validity of the Commitment to Physical Activity Scale for Adolescents. Am J Health Promot. 2017 Jul;31(4):343-352. doi: 10.4278/ajhp.150114-QUAN-665. Epub 2016 Nov 17.

    PMID: 26730556BACKGROUND
  • Gammon C, Pfeiffer KA, Kazanis A, Ling J, Robbins LB. Cardiorespiratory fitness in urban adolescent girls: associations with race and pubertal status. J Sports Sci. 2017 Jan;35(1):29-34. doi: 10.1080/02640414.2016.1154594. Epub 2016 Mar 4.

    PMID: 26942487BACKGROUND
  • Robbins LB, Ling J, Toruner EK, Bourne KA, Pfeiffer KA. Examining reach, dose, and fidelity of the "Girls on the Move" after-school physical activity club: a process evaluation. BMC Public Health. 2016 Jul 30;16:671. doi: 10.1186/s12889-016-3329-x.

    PMID: 27473613BACKGROUND
  • Bakhoya M, Ling J, Pfeiffer KA, Robbins LB. Evaluating Mailed Motivational, Individually Tailored Postcard Boosters for Promoting Girls' Postintervention Moderate-to-Vigorous Physical Activity. Nurs Res. 2016 Sep-Oct;65(5):415-20. doi: 10.1097/NNR.0000000000000173.

    PMID: 27579509BACKGROUND
  • Ling J, Robbins LB. Psychometric Evaluation of Three Psychosocial Measures Associated With Physical Activity Among Adolescent Girls. J Sch Nurs. 2017 Oct;33(5):344-354. doi: 10.1177/1059840516685857. Epub 2016 Dec 29.

    PMID: 28030983BACKGROUND
  • Voskuil VR, Pierce SJ, Robbins LB. Comparing the Psychometric Properties of Two Physical Activity Self-Efficacy Instruments in Urban, Adolescent Girls: Validity, Measurement Invariance, and Reliability. Front Psychol. 2017 Aug 3;8:1301. doi: 10.3389/fpsyg.2017.01301. eCollection 2017.

    PMID: 28824487BACKGROUND
  • Robbins LB, Ling J, Resnicow K. Demographic differences in and correlates of perceived body image discrepancy among urban adolescent girls: a cross-sectional study. BMC Pediatr. 2017 Dec 6;17(1):201. doi: 10.1186/s12887-017-0952-3.

    PMID: 29207976BACKGROUND
  • Robbins LB, Ling J, Dalimonte-Merckling DM, Sharma DB, Bakhoya M, Pfeiffer KA. Sources and Types of Social Support for Physical Activity Perceived by Fifth to Eighth Grade Girls. J Nurs Scholarsh. 2018 Mar;50(2):172-180. doi: 10.1111/jnu.12369. Epub 2017 Dec 21.

    PMID: 29266689BACKGROUND
  • Robbins LB, Ling J, Wen F. Moderators in a physical activity intervention for adolescent girls. Pediatr Res. 2020 Nov;88(5):810-817. doi: 10.1038/s41390-020-0818-5. Epub 2020 Mar 2.

  • Pfeiffer KA, Robbins LB, Ling J, Sharma DB, Dalimonte-Merckling DM, Voskuil VR, Kaciroti N, Resnicow K. Effects of the Girls on the Move randomized trial on adiposity and aerobic performance (secondary outcomes) in low-income adolescent girls. Pediatr Obes. 2019 Nov;14(11):e12559. doi: 10.1111/ijpo.12559. Epub 2019 Jul 3.

  • Robbins LB, Ling J, Sharma DB, Dalimonte-Merckling DM, Voskuil VR, Resnicow K, Kaciroti N, Pfeiffer KA. Intervention Effects of "Girls on the Move" on Increasing Physical Activity: A Group Randomized Trial. Ann Behav Med. 2019 Mar 28;53(5):493-500. doi: 10.1093/abm/kay054.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Costs were not analyzed. Attendance at the physical activity (PA) club was less than optimal. Study lacked a plan for girls to sustain PA in post-intervention period. Generalizability may be limited (sample selected from certain geographical area).

Results Point of Contact

Title
Dr. Lorraine Robbins
Organization
Michigan State University College of Nursing

Study Officials

  • Lorraine B Robbins, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 23, 2011

First Posted

January 4, 2012

Study Start

September 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 21, 2018

Results First Posted

November 21, 2018

Record last verified: 2018-11

Locations